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oai:recercat.cat:11351/77552025-10-24T10:20:18Zcom_2072_378070com_2072_378040col_2072_378092

Efficacy and safety of lurbinectedin and doxorubicin in relapsed small cell lung cancer: results from an expansion cohort of a phase I study Forster, Martin López-Criado, María Pilar Braña Garcia, Irene Flynn, Michael Moreno, Victor Olmedo García, María Eugenia Institut Català de la Salut [Olmedo ME] Hospital Ramon y Cajal, Madrid, Spain. [Forster M, Flynn M] University College of London Hospital and UCL Cancer Institute, London, UK. [Moreno V] START Madrid – FJD (Hospital Fundación Jiménez Díaz), Madrid, Spain. [López-Criado MP] M.D. Anderson Cancer Center, Madrid, Spain. [Braña I] Vall d’Hebron Hospital Universitari, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Pulmons - Càncer - Tractament Quimioteràpia combinada Avaluació de resultats (Assistència sanitària) DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Small Cell Lung Carcinoma Other subheadings::Other subheadings::Other subheadings::/drug therapy ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma pulmonar de células pequeñas Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento Lurbinectedin; Phase I study; Small cell lung cancer Lurbinectedina; Estudio fase I; Cáncer de pulmón de células pequeñas Lurbinectedina; Estudi de fase I; Càncer de pulmó de cèl·lules petites Background A phase I study found remarkable activity and manageable toxicity for doxorubicin (bolus) plus lurbinectedin (1-h intravenous [i.v.] infusion) on Day 1 every three weeks (q3wk) as second-line therapy in relapsed small cell lung cancer (SCLC). An expansion cohort further evaluated this combination. Patients and methods Twenty-eight patients with relapsed SCLC after no more than one line of cytotoxic-containing chemotherapy were treated: 18 (64%) with sensitive disease (chemotherapy-free interval [CTFI] ≥90 days) and ten (36%) with resistant disease (CTFI <90 days; including six with refractory disease [CTFI ≤30 days]). Results Ten patients showed confirmed response (overall response rate [ORR] = 36%); median progression-free survival (PFS) = 3.3 months; median overall survival (OS) = 7.9 months. ORR was 50% in sensitive disease (median PFS = 5.7 months; median OS = 11.5 months) and 10% in resistant disease (median PFS = 1.3 months; median OS = 4.6 months). The main toxicity was transient and reversible myelosuppression. Treatment-related non-hematological events (fatigue, nausea, decreased appetite, vomiting, alopecia) were mostly mild or moderate. Conclusion Doxorubicin 40 mg/m2 and lurbinectedin 2.0 mg/m2 on Day 1 q3wk has shown noteworthy activity in relapsed SCLC and a manageable safety profile. The combination is being evaluated as second-line therapy for SCLC in an ongoing, randomized phase III trial. Clinical trial registration www.ClinicalTrials.gov code: NCT01970540. Date of registration: 22 October, 2013. This work was supported by Pharma Mar, S.A. 2022-06-29T06:58:19Z 2022-06-29T06:58:19Z 2021-10 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Olmedo ME, Forster M, Moreno V, López-Criado MP, Braña I, Flynn M, et al. Efficacy and safety of lurbinectedin and doxorubicin in relapsed small cell lung cancer: results from an expansion cohort of a phase I study. Invest New Drugs. 2021 Oct;39:1275–83. 1573-0646 https://hdl.handle.net/11351/7755 10.1007/s10637-020-01025-x 33704620 000627662400003 http://hdl.handle.net/11351/7755 eng Investigational New Drugs;39 https://doi.org/10.1007/s10637-020-01025-x Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf Springer Scientia